GELATO PERIO MAINTENANCE RINSE- stannous fluoride concentrate 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient:

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Purpose:

Anticavitiy, antigingivitis, antihypersensitivity mouthrinse

Indications and Usage:

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.

Warnings:

  • Keep out of reach of children.
  • Do not swallow. If more than is used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Do not use until diluted.
  • This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Directions:

Adults and children 6 years of age and older:

  • Do not use before mixing with water. Use immediately after preparing the rinse.
  • Remove cap and replace with pump.
  • Roate spout counter clockwise to extend.
  • Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
  • Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age:

  • Consult a dentist or doctor. 

Inactive Ingredients:

Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.

Other Information:

Store at controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.

GelatoPerioRaspberry

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GELATO PERIO MAINTENANCE RINSE 
stannous fluoride concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-206
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (Fluoride Ion) Fluoride Ion1.786 g  in 283.5 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
METHYLPARABEN 
PROPYLPARABEN 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-206-10283.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
Establishment
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc078654194manufacture(68400-206), label(68400-206)

Revised: 5/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.